Effect of vitaminD3 or 25(OH)D3 Fortified Dairy on Vitmain D Status and CVD Risk Markers

Cardiovascular Diseases Clinical Trial

Official title:

Fortification of Milk and Butter With Either vitaminD3 or 25(OH)D3: The Effect on Vitamin D Status and Cardiovascular Disease Risk Markers in Humans

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02535910
• Other study ID #: VitD
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 28, 2015
• Last updated: September 23, 2015
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: September 2015
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the acute effect of consuming milk and butter fortified with either vitamin D3 or 25 (OH) D3 on serum/plasma vitamin D status in humans. In addition, the effect of vitamin D3 or 25 (OH) D3 in milk and butter on certain CVD risk markers and cognitive function will be examined.

Description:

There is mounting evidence to show that vitamin D deficiency may increase the risk of many common and serious diseases, including osteoporosis, cardiovascular disease, some cancers and type 1 diabetes (Holick and Chen, 2008). Hypovitaminosis D is now prevalent in the UK general population. Due to diet and lifestyle changes and the use of sun block products most people do not endogenously synthesise sufficient vitamin D from sunlight exposure (Hyppönen and Power, 2007). Therefore, vitamin D intakes from dietary sources have become very important, however this is limited as there are only a few foods naturally rich in vitamin D.

Some countries (e.g. USA, Canada) fortify milk with vitamin D which results in milk being the major contributor to vitamin D intake. Vitamin D3 is the most common form used for the fortification of currently fortified foods. However, there is now some evidence that 25(OH)D3 can increase vitamin D status of humans more effectively than vitamin D3 (Bischoff-Ferrari et al, 2012; Cashman et al, 2012). To our knowledge, very few human intervention studies have compared the efficacy of 25(OH)D3 versus vitamin D3 to increase vitamin D status, and there has been no acute human study to examine the effect of the both forms of vitamin D fortified dairy products on vitamin D status in humans.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 18
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI: 20-35 kg/m2

• Glucose <7 mmol/l (not diagnosed with diabetes)

• Total cholesterol <7 mmol/l

• TAG <4 mmol/l

• Serum 25(OH)D3 =50 nmol/L

• Normal liver and kidney function

• Haemoglobin: adult male >125 g/L

Exclusion Criteria:

• Milk allergy/intolerance or lactose intolerance

• Cardiovascular, renal, gastrointestinal, respiratory, endocrine disease or cancer

• Use of nutritional supplements, particularly those containing vitamin D

• Outdoor workers and use of tanning beds

• Overseas holidays two months before or during study period

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Avitaminosis
• Cardiovascular Diseases
• Hypovitaminosis D
• Rickets
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• vitamin D3
Subjects are asked to consume a breakfast rich in 20 µg vitamin D3
• 25(OH) D3
Subjects are asked to consume a breakfast rich in 20 µg 25(OH)D3
• Control
Subjects are asked to consume a breakfast without vitamin D

Locations

Country	Name	City	State
United Kingdom	Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the concentrations of vitamin D3, 25(OH)D3, 1, 25(OH)2D3 of the blood		Acute study: measured at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour	No
Primary	Change from baseline in the concentrations of vitamin D3 and 25(OH)D3 of the chylomicron		Acute study: measured at 0 (baseline), 3, 6, 8 hour	No
Secondary	change from baseline in vascular reactivity measured by Endo-PAT		Acute study: measured at 0 (baseline) and the 24 hour	No
Secondary	change from baseline in vascular reactivity measured by digital volume pulse (DVP)		Acute study: measured at 0 (baseline), 120, 240, 360, 480 min and 24 hour	No
Secondary	change from baseline in plasma lipids (primarily triacylglycerol, apolipoprotein B, apolipoprotein B-48, apolipoprotien B-100, total-cholesterol, HDL-cholesterol, non-esterified fatty acids)	non-esterified fatty acids, apolipoprotein B, apolipoprotein B-48, apolipoprotein B-100 are taken at 0(baseline), 60, 120, 240, 360, 480 min and 24 hour; triacylglycerol is taken at 0, 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour; total and HDL-cholesterol only be measured at 0 (baseline)	from 0 to 24 hour, but different measured time points for diferent lipids	No
Secondary	change from baseline in markers of insulin resistance (glucose and insulin)		Acute study: measured at 0, 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour	No
Secondary	change from baseline in nitric oxide		Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour	No
Secondary	change from baseline in inflammatory markers (tumor necrosis factor alpha, C-reactive protein and interleukin 6) of the blood		Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour	No
Secondary	change from baseline in blood pressure		Acute study: measured at 0, 120, 240, 360, 480 min and 24 hour	No
Secondary	change from baseline in cognitive test	Trail Making Test (TMT) will be used for cognitive test, which can provides information on visual search, scanning, speed of processing, mental flexibility, and executive function. The TMT consists of two parts: TMT-A requires a participant to draw lines sequentially connecting 25 encircled numbers distributed on a computer screen, whilst in the TMT-B the participant must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). TMT-A and TMT-B will be administered using a laptop computer. Results from this two tasks reported as the number of seconds required to complete the task (completion time). The longer time spent reveal greater cognitive impairment."	Acute study: measured at 0, 480 min and 24 hour	No